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ABSTRAL Fentanyl sublingual tablets is a solid formulation of fentanyl citrate, a mighty opioid analgesic supposed for oral sublingual management. ABSTRAL is formulated as a white tablet to be had in six strengths, distinguishable by means of the shape of the tablet and by de-bossing on the pill floor.
active component: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a notably lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in natural solvents and sparingly soluble in water (1:40). The molecular weight of the loose base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.three and eight.4.
All pill strengths are expressed as the amount of fentanyl unfastened base, e.g., the 800 mcg energy pill contains 800 mcg of fentanyl loose base.
Inactive ingredients: Croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.
ABSTRAL (fentanyl) sublingual pills are indicated for the management of step forward pain in most cancers sufferers 18 years of age and older who are already receiving and who are tolerant to opioid remedy for their underlying continual cancer ache. sufferers considered opioid tolerant are individuals who are taking around-theclock medication including at least 60 mg of oral morphine day by day, or at the least 25 mcg of transdermal fentanyl/hour, or at the least 30 mg of oral oxycodone each day, or at the least 8 mg of oral hydromorphone every day or at least 25 mg oral oxymorphone each day, or an equianalgesic dose of another opioid remedy day by day for a week or longer. sufferers should continue to be on around-the-clock opioids whilst taking ABSTRAL.
Abstral Fentanyl Sublingual Tablets is contraindicated for sufferers who aren’t already tolerant to opioids because lifestyles-threatening respiratory depression and dying should result at any dose in sufferers not on a chronic routine of opioids. for that reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental ache, or use in the emergency room.
Abstral Fentanyl Sublingual Tablets is supposed to be prescribed most effective by means of healthcare experts who are knowledgeable of, and skilled in, the use of time table II opioids to treat cancer pain.
Obstacles of Use
As a part of the TIRF REMS get entry to application, ABSTRAL can be dispensed most effective to outpatients enrolled within the software [see WARNINGS AND PRECAUTIONS]. For inpatient management of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment isn’t always required.
DOSAGE AND administration
Healthcare specialists who prescribe ABSTRAL on an outpatient basis ought to join inside the TIRF REMS get entry to software and comply with the requirements of the REMS to make certain safe use of ABSTRAL [See WARNINGS AND PRECAUTIONS].
as with any opioids, the protection of sufferers the use of such products is depending on health care professionals prescribing them in strict conformity with their permitted labeling with recognize to patient selection, dosing, and right situations for use.
The objective of dose titration is to become aware of an effective and tolerable preservation dose for ongoing control of step forward cancer ache episodes. The effective and tolerable dose of ABSTRAL will be decided with the aid of dose titration in individual patients.
cautiously supervise sufferers until a dose that provides adequate analgesia with tolerable side outcomes is reached for breakthrough ache manage